Field of the Invention
The invention generally relates to a medical device, method and system thereof for the placement or passage of patches, sutures, anchors, tags, tissue sensors and more particularly to a medical device for repairing female pelvic organ or tissue prolapsed region.
Discussion of the Related Art
It is estimated that nearly twelve percent of women will need surgery for pelvic organ prolapse. Historically, the long term result of these surgeries using the patient's own tissue for the repair, has been disappointing for both the patients and the surgeons. Recurrence of prolapse after standard autologous tissue repairs has been reported to be as high as about thirty percent to about forty percent.
Many current methods for pelvic reconstruction use instruments designed for laparoscopic surgery. These devices allow the surgeon to suture or anchor tissue, or to staple a patch or graft material into place. While laparoscopic instruments may be effective for laparoscopy when used under direct visualization, they tend to be less effective when used used in conditions of limited space and visualization, e.g., the vagina. More specifically, when laparoscopic instruments are used for vaginal surgery, there is a lack of tactile assistance or feedback when working from the end of an instrument. In addition, laparoscopic instruments are rigid and therefore not suited to the angles and planes encountered in vaginal surgery.
Methods, techniques and devices were developed that use a perineal approach. In these techniques, needles or carriers are placed through the skin of the perineum (outside the vagina) and into the pelvis and vagina. Once in position, graft material is attached to the needles which are drawn brought back out to the external skin, pulling the graft into position.
Moreover, these related art instruments are difficult to use with a perineal approach. Moreover, as the perineal approach is not widely taught, or familiar to many surgeons it is not a general skill of most surgeons, and it requires passage of a needle/carrier blindly through a great distance of tissue. Therefore, the difficulty of these techniques and related art devices limit their use to a very few specialists who are able to perform them, thereby limiting the availability of the treatment. Furthermore, this percutaneous approach has resulted in additional possible surgical complications, including infections, surrounding organ injuries, and painful scarring.
Other currently available methods and instruments available use a more traditional and familiar vaginal approach. These are generally sold as a kit, which include rigid devices used to aid in the attachment of graft materials. The graft is preformed and specific to the repair being done, i.e., anterior, posterior or apical. Currently available methods and instruments for the vaginal approach to prolapse repair utilize surgical skills and anatomical landmarks familiar to most gynecologists. However, the cost associated with the kits, the generally rigid and unwieldy nature of these devices render these kits problematic.
Therefore, there is a need for a device, method and/or system that addresses the above and other problems.